Public Assessment Report Repeat-Use Mutual …

1 Public Assessment Report Repeat-Use Mutual recognition Procedure versatis 5 % medicated PLASTER LIDOCAINE 5% medicated PLASTER (Lidocaine) Procedure No: UK/H/1040-1041/001/E03 UK Licence No: PL 21727/0016-0017 Grunenthal Limited MRPAR Versatis/Lidocaine 5% medicated Plaster UK/H/1040-1041/001/E03 2 LAY SUMMARY versatis 5 % medicated PLASTER LIDOCAINE 5% medicated PLASTER (lidocaine) This is a summary of the Public Assessment Report (PAR) for Versatis/Lidocaine 5% medicated Plaster (PL 21727/0016-0017). It explains how Versatis/Lidocaine 5% medicated Plaster w as assessed and its authorisation recommended, as well as its conditions of use.

2 It is not intended to provide practical advice on how to use Versatis/Lidocaine 5% medicated Plaster. For practical information about using Versatis/Lidocaine 5% medicated Plaster, patients should read the package leaflet or contact their doctor or pharmacist. Versatis/Lidocaine 5% medicated Plaster will be referred to as Versatis/Lidocaine in this Report . What is Versatis/Lidocaine and what is it used for? Versatis/Lidocaine is used to provide relief in a painful skin condition called post-herpetic neuralgia. This is generally characterised by localised symptoms such as burning, shooting pain or stabbing pain.

3 Versatis/Lidocaine is not recommended for use in patients under 18 years of age. How does Versatis/Lidocaine work? The active ingredient in Versatis/Lidocaine is lidocaine, which is a local anaesthetic. Lidocaine works by reducing pain in the skin. How is Versatis/Lidocaine used? Versatis/Lidocaine is available as a medicated plaster and the route of administration is application to the skin. Versatis/Lidocaine 5% medicated Plasters should be applied to the painful area of skin. This medicine should be used exactly as advised by the prescribing doctor. The patient should check with the doctor or pharmacist if unsure.

4 The usual daily dose is to use between one and three plasters of the size of the painful areas of skin. Versatis/Lidocaine may be cut into smaller pieces to fit the affected area. Not more than 3 plasters should be used at the same time. The plasters should be removed after 12 hours of use, so that the patient has a 12 hour period with no plaster. Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment. Versatis/Lidocaine can only be obtained with a prescription. What benefits of Versatis/Lidocaine have been shown in studies?

5 Grunenthal Limited provided its own data on efficacy and safety studies. These studies have shown that Versatis/Lidocaine is effective in the treatment of post-herpetic neuralgia. MRPAR Versatis/Lidocaine 5% medicated Plaster UK/H/1040-1041/001/E03 3 What are the possible side effects of Versatis/Lidocaine? Like all medicines, Versatis/Lidocaine can cause side effects, although not everybody gets them. If irritation or burning sensation occurs whilst using the plaster, the plaster should be removed. The area of irritation should remain plaster-free until the irritation stops. Very common side effects which may affect more than 1 in 10 people are listed below.

6 These include skin conditions at or around the site of plaster application, which may include redness, rash, itching, burning, dermatitis, and small blisters. For the full list of all side effects reported with Versatis/Lidocaine, see section 4 of the package leaflet available on the MHRA website. Why was Versatis/Lidocaine approved? The MHRA decided that the benefits of Versatis/Lidocaine are greater than its risks and recommended that it be approved for use. What measures are being taken to ensure the safe and effective use of Versatis/Lidocaine? A risk management plan has been developed to ensure that Versatis/Lidocaine is used as safely as possible.

7 Based on this plan safety information has been included in the Summary of Product Characteristics and the package leaflet for Versatis/Lidocaine including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about Versatis National Marketing Authorisations for Versatis/Lidocaine 5% medicated Plaster (PL 21727/0016-0017) were granted in the UK on 05 January 2007 to Gr nenthal Limited. Versatis/Lidocaine 5% medicated Plaster (PL 21727/0016-0017) then went through a first wave Mutual recognition Procedure (MRP; UK/H/1040-1041/001/MR) involving Belgium, Germany, France, Luxembourg, Sweden and Slovenia.

8 The procedure was completed on 27 September 2007. A second-wave MRP (UK/H/1040-1041/001/E01) involving the Concerned Member States Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Greece, Spain, Iceland, Lithuania, Latvia, Malta, Portugal, Romania and Slovak Republic was concluded on 23 December 2009. Versatis/Lidocaine 5% medicated Plaster (PL 21727/0016-0017) then went through a third-wave MRP (UK/H/1040-1041/001/E02) involving Denmark, Finland, Hungary, Ireland, Italy, Norway and Poland. This procedure was completed on 28 July 2010. A fourth-wave MRP (UK/H/1040-1041/001/E03) involving the Netherlands as Concerned Member State was concluded on 09 December 2013.

9 MRPAR Versatis/Lidocaine 5% medicated Plaster UK/H/1040-1041/001/E03 4 The full PAR for Versatis/Lidocaine follows this summary. For more information about treatment with Versatis/Lidocaine, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in March 2015. MRPAR Versatis/Lidocaine 5% medicated Plaster UK/H/1040-1041/001/E03 5 TABLE OF CONTENTS I Introduction Page 6 II Quality aspects Page 7 III Non-clinical aspects Page 8 IV Clinical aspects Page 10 V User consultation Page 24 VI Overall conclusion, benefit/risk Assessment and recommendation Page 25 Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL)

10 And Labels Page 26 Annex 1 - Table of content of the PAR update for MRP and DCP Page 29 Annex Page 31 Annex Page 35 Annex Page 39 Annex Annex Page 42 Page 43 MRPAR Versatis/Lidocaine 5% medicated Plaster UK/H/1040-1041/001/E03 6 I Introduction Based on the review of the data on quality, safety and efficacy the Netherlands considered that the applications for versatis 5 % medicated Plaster (PL 21727/0016) and Lidocaine 5% medicated Plaster (PL 21727/0017) could be approved via the Mutual recognition Procedure (UK/H/1040-1041/001/E03). The products are prescription-only medicines. These are a set of parallel applications for one strength of medicated plasters (5% lidocaine), submitted as full dossier applications according to Article of Directive 2001/83/EC.